Abhijeet Shingate
Global Lead -Qualification and Validation
- Role
- Lead -report Issuance (Qualifications and Validation) at Sanofi
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Abhijeet Shingate
With 15+ years of immerse experience in the pharmaceutical industry, I specialize in Production activities, validation, qualification, and project management with a focus on operational excellence and regulatory compliance. In Sanofi India limited, Goa ( Production department)Key responsibilities • Preparation and execution of Production plan, with key focus on timely supply of WORLDS BEST IN CLASS MEDICINES patients. • Leading team of around 60+ people in plant of annual capacity of 500 billion tablet. • Budget planning for production. • Active participation in MSEP (Mon source exit plan for RM, PM API ).• Product transfers -Several Global Product Transfers.(Defining strategy for product transfer, cost effectiveness, adhering to timelines for transfers etc) Many Domestic product transfers • Qualified Third-Party Auditor (API, Excipient, Packing material, testing laboratory). • Handling of market complaint.(Investigation, Root cause analysis, CAPA implementation)• Strengthening the production with HSE norms culture, QMS aspects, Data integrity, lean principles and many more. • Strong collaboration with HSE, Quality, Supply chain for effective, healthy, competitive environment on production shopfloor. • Defining validation plans and strategies for product robustness.• Controlling and Monitoring the inventories.• Monthly meeting with Controlling and defining action plan for slow moving materials and inventories.Achievements -• 5.20 billion tablet production in 2019 highest ever in history of Goa site. • Global product transfers (South Africa to Goa),(Frankfurt to Goa),(Brazil to Goa) in less than defined timeline.• Increase in production capacity by 40 % by effectively utilization of lean tools. • Successfully handled the site audits like MHRA, TGA, MCC, ANVISA, WHO. • True success from MSEP for getting alternate coating material for many products, Excipient replacements which resulted in great savings. My VisionTo continue growing as a leader in pharmaceutical operations while contributing to a healthier, more efficient world.
Experience
Lead -report Issuance (Qualifications and Validation)
Apr 2025 — Present · Hyderabad, IN
Education
SAHYADRI COLLEGE OF PHARMACY METHWADE TAL . SANGOLA DIST-SOLAPUR
Bachelor of Pharmacy (B.Pharm.)
2007 — 2010
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